Medicine
Mycophenolate 360 mg delayed-release tablet
Mycophenolate 360 mg delayed-release tablet is a generic prescription medicine for oral use, made by 15 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.
Key facts
- Active ingredient (INN)
- Mycophenolate
- Brand
- Sold under the generic name
- Strength
- 360 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 500 tablets, 120 tablets, 10 blister pack and 22 more
- Manufacturers
- Ascend LaboratoriesIndiaBioconIndiaConcord BiotechIndiaAccord HealthcareIndiaAurobindo PharmaIndiaMajor PharmaceuticalsA-S Medication SolutionsAdvagen PharmaAmerican Health PackagingApotex
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AA06 Mycophenolate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 August 2014
- Identifiers
- RxCUI 485020, 485023DailyMed set ID cbc3e916-09e2-4e6e-9e5e-98375f5e6d41, c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0, 6b170816-6e5c-400c-b97b-82bbbb7d4925 +15NDC 82293-013, 60505-2966, 0904-7372 +15Application ANDA216637, ANDA091558, ANDA208315 +6
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet, delayed release in 1 bottle | 67877-427-05 | Ascend LaboratoriesIndia | 24 September 2021 |
| 120 tablet, delayed release in 1 bottle | 67877-427-12 | Ascend LaboratoriesIndia | 24 September 2021 |
| 10 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack | 67877-427-38 | Ascend LaboratoriesIndia | 24 September 2021 |
| 500 tablet, delayed release in 1 bottle | 67877-929-05 | Ascend LaboratoriesIndia | 21 April 2026 |
| 120 tablet, delayed release in 1 bottle | 67877-929-12 | Ascend LaboratoriesIndia | 21 April 2026 |
| 10 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack | 67877-929-38 | Ascend LaboratoriesIndia | 21 April 2026 |
| 120 tablet, delayed release in 1 bottle | 70377-040-11 | BioconIndia | 30 May 2022 |
| 120 tablet, delayed release in 1 bottle | 70377-127-11 | BioconIndia | 30 September 2024 |
| 120 tablet, delayed release in 1 bottle | 16729-189-29 | Accord HealthcareIndia | 11 September 2017 |
| 120 tablet, delayed release in 1 bottle | 59651-622-08 | Aurobindo PharmaIndia | 27 February 2024 |
| 120 tablet, delayed release in 1 bottle | 68254-5002-1 | Concord BiotechIndia | 13 December 2019 |
| 500 tablet, delayed release in 1 bottle | 68254-5002-2 | Concord BiotechIndia | 13 December 2019 |
| 120 tablet, delayed release in 1 bottle | 72888-200-12 | Advagen Pharma | 10 November 2023 |
| 120 tablet, delayed release in 1 bottle | 60505-2966-7 | Apotex | 19 August 2014 |
| 120 tablet, delayed release in 1 bottle | 82293-013-10 | Novugen Pharma | 1 September 2024 |
| 120 tablet, delayed release in 1 bottle | 70436-173-23 | Slate Run Pharmaceuticals | 19 May 2021 |
| 120 tablet, delayed release in 1 bottle | 85972-162-12 | Stellon Biotech | 11 September 2026 |
| 30 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack | 0904-6786-04 | Major Pharmaceuticals | 19 August 2014 |
| 100 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack | 0904-6786-61 | Major Pharmaceuticals | 19 August 2014 |
| 30 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack | 0904-7372-04 | Major Pharmaceuticals | 15 April 2025 |
| 100 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack | 0904-7372-61 | Major Pharmaceuticals | 15 April 2025 |
| 180 tablet, delayed release in 1 bottle | 50090-6492-0 | A-S Medication Solutions | 22 May 2023 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, delayed release in 1 blister pack | 68084-918-25 | American Health Packaging | 2 April 2015 |
| 120 tablet, delayed release in 1 bottle | 60429-017-12 | Golden State Medical Supply | 13 October 2014 |
| 30 pouch in 1 box / 1 tablet, delayed release in 1 pouch | 70518-4391-0 | Remedyrepack | 15 July 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Mycophenolate 360 mg delayed-release tablet.
Other strengths and forms of Mycophenolate
Clinical summary
Mycophenolate is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. MedsAcross supplies Mycophenolate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MycophenolateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CellCept prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- CellCept: European public assessment report (EPAR) · European Medicines Agency
- Myclausen: European public assessment report (EPAR) · European Medicines Agency
Need Mycophenolate 360 mg delayed-release tablet for your hospital or patient?
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